Phase II Neoadjuvant ER+/PgR + Arimidex +/- Iressa Study

AstraZeneca185 enrolled

Overview

The purpose of this study is to compare the changes in a proliferation biomarker in subjects receiving Anastrozole or Anastrozole/ZD1839 combination.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

185

Conditions

Breast Cancer

Interventions

AnastrazoleDRUG

GefitinibDRUG

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

Inclusion Criteria: * Measurable (stage I-IIIB) non meta static non inflammatory breast cancer * Patients must post menopausal women who in the opinion of investigator would be likely to benefit from endocrine therapy. Postmenopausal patients are defined as: * Natural menopause with last menses \> 1 year ago, * Radiation induced oophorectomy with last menses \> 1 year ago, * Serum FSH and LH levels clearly in the postmenopausal range for the institution. * Bilateral oophorectomy Exclusion Criteria: * Other current or previous (to last 5 years) malignancies, other metastases, abnormal blood chemistry, lung/ heart/kidney/liver abnormalities, * Hormonal treatment within the last 2 weeks, previous hormonal treatment for invasive cancer

Locations (34)

Research Site

Brno, Czechia

Outcomes

Primary Outcomes

To determine and compare changes in proliferation marker at 16 weeks in the treatment groups

Secondary Outcomes

Tumour response, safety and tolerability, pharmacokinetics, pharmacokinetics and dynamics, oestradiol levels, mastectomy rate.

Comparison of WHO and RECIST criteria,

Exploratory biomarker studies involving genomics, metabolomics and proteomics.

Data from ClinicalTrials.gov

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